Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hydrocortisone and lidocaine · 1 trial · 1 indication
A measure overall discomfort on a scale of 0 to 5
| Arm | Type | Description |
|---|---|---|
| Vehicle cream | PLACEBO_COMPARATOR | Placebo control base cream |
| 3% hydrocortisone | EXPERIMENTAL | 3% Hydrocortisone acetate cream |
| 0.5% hydrocortisone | EXPERIMENTAL | 0.5% Hydrocortisone acetate cream |
| 5% lidocaine | EXPERIMENTAL | 5% Lidocaine hydrochloride cream |
| 1% lidocaine | EXPERIMENTAL | 1% Lidocaine hydrochloride cream |
| 3% Hydro 5% Lido | EXPERIMENTAL | Hydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream |
| 0.5% Hydro 1% Lido | EXPERIMENTAL | Hydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream |
| Name | Type | Description |
|---|---|---|
| Hydrocortisone acetate and lidocaine hydrochloride | DRUG | Hydrocortisone and lidocaine in combination |
| Placebo control | DRUG | Vehicle cream alone |
| Hydrocortisone acetate | DRUG | hydrocortisone alone |
| Lidocaine hydrochloride | DRUG | lidocaine alone |
Inclusion Criteria: 1. Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study. 2. Subject has p...
Hydrocortisone and lidocaine is an investigational small molecule combination being studied for the treatment of hemorrhoids. It is being developed by Citius Pharmaceuticals, Inc. (ticker CTXR) and has been evaluated in a Phase 2 clinical trial in adults with Grade I and II hemorrhoids.
Hydrocortisone and lidocaine combines hydrocortisone, which acts as an agonist at the glucocorticoid receptor NR3C1, with lidocaine, a local anesthetic. The hydrocortisone component targets NR3C1, while lidocaine provides local numbing. The combination is designed to address the inflammation and discomfort associated with hemorrhoids.
Citius Pharmaceuticals, Inc., which trades under the ticker CTXR, is the developer of the hydrocortisone and lidocaine combination product for hemorrhoids. The company is advancing the asset as an investigational therapy in its gastrointestinal pipeline.
Hydrocortisone and lidocaine is in Phase 2 development for hemorrhoids. It is investigational and has not been approved by the FDA. The Phase 2 program has been completed, with one completed trial and no active trials currently listed.
Hydrocortisone and lidocaine has been studied in the Phase 2 trial NCT02689856, titled Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids. The trial was completed, enrolled 211 participants, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.